The University of Brescia is the Italian reference center for adrenocortical carcinoma. The scientific journal Lancet Endocrinology recently published the first international randomized study - Adjuvant mitotane versus surveillance in low-grade, localized adrenocortical carcinoma (ADIUVO) - conducted on patients with adrenocortical carcinoma who underwent radical surgical resection and were at low/intermediate risk of recurrence. The study aimed to evaluate the efficacy and safety of adjuvant mitotane compared to surveillance alone, considering its toxicity. The study, born from the collaboration between the University of Turin and the University of Brescia, is set in the context of an exceptionally rare disease, with an incidence of 1 case per 1,000,000 people in Western countries. Surgery is the only treatment capable of offering patients a "chance" of cure, but unfortunately, the proportion of patients who relapse after surgery is generally high. The study was conducted in 23 centers in seven countries: between October 23, 2008, and December 27, 2018, 45 patients were randomly assigned to receive mitotane and 46 to active surveillance. The 5-year recurrence-free survival was 79% in the group that took mitotane and 75% in the surveillance group. The study shows that adjuvant mitotane is not recommendable in patients with low-risk adrenocortical carcinoma after radical surgery, considering the relatively good prognosis of these patients and the absence of significant improvement in recurrence-free survival and toxicity associated with treatment.
"The results of this study do not demonstrate a benefit of treatment in these patients since the progression-free survival and overall survival were not different in the two arms" declares Prof. Alfredo Berruti, Full Professor of Medical Oncology at the University of Brescia and co-coordinator of the study. "However, the important data emerges that in this subgroup with a favorable prognosis, 75% of patients undergoing surgery alone did not relapse after five years and can therefore be considered cured. This percentage far exceeds what we had anticipated when the study was designed (60%). In summary, thanks to Italian research initially coordinated by the University of Turin and subsequently by the collaboration of the University of Turin with the University of Brescia, it was first introduced the concept that a winning strategy, in the treatment of patients suffering from adrenocortical carcinoma, is to reduce the risk of post-surgical recurrence with a preventive treatment based on mitotane. Later, in the study recently published, it was demonstrated that there is a subgroup of patients with a very good prognosis in which treatment with this drug is generally not advantageous and can be avoided".